Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, today announced the publication of a new multi-domain model for capturing functional status in oncology through connected digital tools in Clinical & Translational Science.
The paper, titled: “A Proposed Multi-Domain Digital Model for Capturing Functional Status and Health-Related Quality of Life in Oncology,” highlights the importance of collecting continuous 24/7 functional status measures digitally to enable better clinical decisions and outcomes assessment. The paper can be found at https://doi.org/10.1111/cts.13712.
Traditional clinical trial endpoints in oncology have long been crucial for evaluating novel treatments. However, the assessment of patients’ functional status – encompassing physical, cognitive, and behavioral functioning – holds increasing significance in influencing clinical decisions and understanding treatment outcomes. Koneksa’s innovative digital model aims to address limitations in existing functional status assessments by leveraging digital health technologies (DHTs) for both objective and self-reported outcomes.
The proposed model encompasses four key domains: physical activity data, vital signs, sleep variables, and health-related quality of life. By utilizing DHTs for data collection, Koneksa’s approach enables high-resolution, real-time measurements of objective data as patients navigate their daily lives outside hospital settings. This is complemented by electronic questionnaires tailored to each concept, ensuring comprehensive data collection.
“We’re introducing a transformative approach to functional status assessment in oncology and other disease areas,” said John Wagner, M.D, Ph.D., Chief Medical Officer, Koneksa. “This new digital measurement model not only addresses the limitations of traditional assessments, but also embraces the power of digital health technologies to capture a holistic assessment of patients’ health experiences.”
“Koneksa’s vision for digitally enabled data collection of functional status has several advantages over traditional approaches, such as more objective measures, as well as enabling a comprehensive understanding of how a patient is functioning outside the hospital setting,” said Elena Izmailova, Ph.D., Chief Scientific Officer, Koneksa. “This digital measurement model has already shown promise in early feasibility studies, and we look forward to applying this model into interventional trials with future partners and studies. Remote data collection also expands study accessibility, enabling a broader and more diverse representation of patients in clinical trials. Moreover, I personally pressure-tested the importance of collecting functional-status data during my own recent treatment for cancer. The results of my patient journey are published in JCO Clinical Cancer Informatics.”
Continuous real-time digital monitoring of functional status can assess the health and well-being of patients in other diseases, such as in orthopedics. Koneksa has also initiated an observational study to explore 24/7 functional status measures in total hip replacement (LEARNT), which recently enrolled its first patient in December 2023. Up to 25 patients will be enrolled in this clinical validation study of 24/7 functional status in orthopedics (hip replacements). The purpose of the study is to evaluate the functional status measurement concept, and to validate algorithms and digital devices (such as smartphone apps, wrist-worn sensors, and other wearable devices) for use in clinical trials.
This new publication builds upon research conducted by Dr. Nitin Ohri at Montefiore Medical Center in collaboration with Koneksa, presented at 2023 ASCO Quality Care. Other groups have also published results of studies highlighting the importance of assessing functional status in cancer patients, which can be seen in PLOS Digital Health and Cancer Medicine
About Koneksa
Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision-making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes. Learn more at koneksahealth.com.
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